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Objective

Founded in 2005, Vectalys is a biotech company that develops world leading gene delivery technologies for industrial and therapeutic applications. Vectalys has built a state-of-the-art proprietary lentiviral vectors (LV) production platform to provide its customers and partners with the highest quality of LV. Based on 10 years of collaborative research, the resulting LV purity is now recognized as a key success factor for cutting-edge stable cell engineering on primary and stem cells. In parallel, thanks to its deep understanding of market needs, Vectalys has developed and patented a game-changing class of RNA carriers called LentiFlash (LF), a new generation of non-integrating LV dedicated to gene-editing applications requiring a transient expression.

Bioprocessing know-how, stable and transient delivery tools and intellectual property combine into a unique and powerful integrated platform capable of accelerating both gene-editing and immunotherapy applications. Based on recent results of early CAR-T cells clinical trials, mainly in the US, the market will now need an extensive scale-up capacity to produce GMP-grade LV and LF. The application potential is significant and includes both clinical approaches (gene therapy, gene-editing, and immunotherapy) and industrial systems (synthetic biology, modelling development).

Compared to the US, there is in Europe a clear lack of clinical manufacturing infrastructure and of integrated platforms that include both research and GMP production, thereby offering a broad expertise from vector design to therapeutic strategies. From a non-regulatory pre-clinical stage market, Vectalys has the capacity to move forward into the clinical stage market as a GMP grade value provider. The company has taken the technological lead in this field in Europe and is now committed to producing these tools at a clinical grade in order to transform the lives of patients with severe genetic and rare diseases as well as untreated cancers.

Founded in 2005, Vectalys is a biotech company that develops world leading gene delivery technologies for industrial and therapeutic applications. Vectalys has built a state-of-the-art proprietary lentiviral vectors (LV) production platform to provide its customers and partners with the highest quality of LV. Based on 10 years of collaborative research, the resulting LV purity is now recognized as a key success factor for cutting-edge stable cell engineering on primary and stem cells. In parallel, thanks to its deep understanding of market needs, Vectalys has developed and patented a game-changing class of RNA carriers called LentiFlash (LF), a new generation of non-integrating LV dedicated to gene-editing applications requiring a transient expression.

Based on recent results of early CAR-T cells clinical trials, mainly in the US, the market will now need an extensive scale-up capacity to produce GMP grade LV and LF. From a non-regulatory pre-clinical stage market, Vectalys has the capacity to move forward into the clinical stage market as a GMP grade value provider. For this reason, the planned steps of development plan are:- Phase I: to assess the technical feasibility and commercial potential of GMP production through the industrial process design, a market study, the intellectual property exploration and meet regulatory compliance demands. - Phase II: to set up a GMP pilot facility to move forward into the clinical stage market, by scaling-up the production line to a manufacturing level.

During the LentiFactory project (SME Instrument Phase I), Vectalys’ objectives were therefore to perform a techno-economic feasibility study to define the strategic plan for the next years, for bringing cost-effective products to the market, and prepare industrial scaling-up. To prepare clinical grade solution suitable, the Phase I LentiFactory project has been dividing into 2 major sections: (i) an industrial strategy development plan, (ii) and an IP & market study and analysis.

The company is now committed to producing these tools at a clinical grade in order to transform the lives of patients with severe genetic and rare diseases as well as untreated cancers.